The mission of Cook County Health’s Institutional Review Board (IRB) is to protect human participants involved in research conducted by or through Cook County Health and to ensure all research is conducted in accordance with ethical principles and all applicable regulations.
The IRB serves as the Board of Record for all Cook County Health affiliates.
The Office of Research & Regulatory Affairs provides: administrative support to the IRB; review process for all protocol applications; feedback to investigator; correspondence with investigators; educational programs and audits.
Federal Wide Assurance (FWA)
Cook County Health IRB has filed a Federal Wide Assurance (FWA) with the Department of Health and Human Services (DHHS), in which we promise to uphold federal regulations and ethical principles for human participants in research conducted by employees, agents and affiliates of Cook County Health.
FWA number: FWA00001802
IRB Registration Information Letter (IORG)
The Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) require IRBs to register through a system maintained by DHHS.
IRB Organization (IORG) number: IORG0000119
Guide for Investigators
The Guide for Investigators is an effort to describe expectations and provide some operational guidance for the ethical conduct of research done at all affiliates of Cook County Health. Our guide is currently under revision. As new sections are completed, they will be posted here.
Guide for Investigators – Under Revision
IRB Manager, our web-based submission system, allows users to enter protocols and protocol related information such as: new submissions, progress reports, adverse events, attachments, comments and more. Investigators have access to see the protocols they’re investigating as well as attachments, events and documents generated for their study.
Please email CCHHSIRB@cookcountyhhs.org at the Office of Research & Regulatory Affairs to obtain a login and password. If you need assistance or would like to schedule a training session, please send an email to the address above.
Templates & Forms
- HRP-012-SOP-Observation of Consent
- HRP-090-SOP-Informed Consent Process
- HRP-091-SOP-Written Documentation of Consent
- HRP-419-Checklist-Waiver of Consent Process for Emergency Research
- HRP-410-Checklist-Waiver of Written Documentation of Consent
- HRP-411-Checklist-Waiver or Alteration of Consent Process
Training for Human Participant Research
All persons who are to be substantively involved in human participant research at Cook County Health must be properly trained.
Research & Regulatory Affairs is excited to introduce the CITI Program for Research Ethics and Compliance Training to Cook County Health. In order to ensure the protection of our research participants, our Human Subjects Research (HSR) / IRB training will now expire every 3 years. With over 800 active users in IRBManager, online certification is necessary to keep up with best practices and law changes, standardize the educational platform across institutions for multisite studies, and ensure our researchers meet single IRB and sponsor requirements.
Researchers looking to become certified for the first time will now complete the HSR CITI modules prior to their in-person training. You must have a Cook County Health ID to attend the in-person session. Researchers who have already completed the in-person training will only have to complete the CITI modules. Researchers who have not taken the in-person training in the last 3 years are required to complete the HSR course by the end of 2019. Those that have completed the in-person training within the last 3 years will be required to renew at their 3-year expiration date.